The Commons Science and Technology Committee have launched a new inquiry looking at clinical trials and the disclosure of data. There is lots of discussion at the moment about how accessible the data gathered from clinical trials is and whether access to this data can be improved and used to help us improve care for patients.
AMRC will be working with our members to respond to the inquiry.
Clinical trials are an essential step in turning a discovery in a lab into a treatment for patients. New drugs must go through a series of controlled tests to ensure they are safe and effective. Clinical trials, involving healthy volunteers or patients, help us establish whether a drug is safe and how well it works. This POSTnote gives a great overview of clinical trials.
An EU Clinical Trials Regulation to update the law governing clinical trials across Europe is currently being debated. AMRC recently supported a joint statement on the proposed changes.
In December 2011, the Health Research Authority was created to protect and promote the interests of patients and the public in health research.
There has been lots of focus recently on improving the availability of data from clinical trials and addressing concerns that it is possible for trials of new drugs to be published selectively, which can skew the evidence available for clinicians making decisions about how best to treat their patients.
The European Medicines Agency has recently announced that it will proactively publish clinical trial data and enable access to full data sets by interested parties. They are setting up working groups to look at some of the practical and policy issues involved in doing this and are looking for members to take part in these groups at the moment.
The British Medical Journal also recently announced that from January 2013, they will only publish scientific papers where there is a commitment to make the relevant anonymised patient level data available on reasonable request.
And there is added focus and momentum on this issue with the publication of Dr Ben Goldacre’s book Bad Pharma which looks at some of these issues in detail.
What is the inquiry looking at?
The committee’s terms of reference are:
1. Do the European Commission’s proposed revisions to the Clinical Trials Directive address the main barriers to conducting clinical trials in the UK and EU.
2. What is the role of the Health Research Authority (HRA) in relation to clinical trials and how effective has it been to date?
3. What evidence is there that pharmaceutical companies withhold clinical trial data and what impact does this have on public health?
4. How could the occurrence and results of clinical trials be made more open to scrutiny? Who should be responsible?
5. Can lessons about transparency and disclosure of clinical data be learned from other countries?
They are asking for written submissions addressing these issues by 22 February 2013.
Medical Research Charities fund clinical trials and are keen to ensure the whole system works to deliver the best healthcare for patients – this includes ensuring data is shared responsibly and effectively and clinicians have access to the best data to make decisions about how to treat their patients.
Much work is already underway to improve research processes and ensure those treating patients can make decisions based on the best evidence – the NHS now has a duty to promote the use of research evidence to improve care. We are working with our members to identify what the key issues are for them and the patients they work with, and where they think the system we work within can be improved. We will respond to the Committee’s inquiry.